The purpose of this study is to determine whether early use of transjugular intrahepatic portosystemic shunt (TIPS) with Polytetrafluoroethylene (PTFE) covered stents is able to prolong the survival in cirrhotic patients with high risk acute variceal bleeding.

A 8 mm Fluency stent will be used, that will be dilated to 8 or 10 mm according to the hemodynamic response. The aim will be to reduce the portal pressure gradient (PPG) below to 25-75% of baseline. Not paralleled TIPS or over-dilatation are allowed.

Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of big portosystemic collaterals feeding the varices, in association with a PPG below 16 mmHg

After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted

Other Name: Transjugular intrahepatic portosystemic shunt (TIPS)

Drug: Non-selective beta blocker + Endoscopic treatment

Patients will begin treatment with non-selective beta-blockers (either propranolol or nadolol). After an initial dose of 40 mg, the dose of propranolol/nadolol will be increased/decreased step by step to achieve a baseline heart rate of 55 bpm or up to the maximum tolerated dose, within the limit of 160 mg twice a day (bid) for propranolol or to a maximum of 160 mg for nadolol.

The first elective session of endoscopic band ligation should be performed within the first 7-14 days. The following sessions will be performed at 14 + 3 days intervals until variceal eradication (defined as disappearance of the varix, impossibility of suctioning the varix, or a maximum of six continued sessions). Once eradication is achieved, a control endoscopy will be performed one month later for confirmation. The following endoscopies will be scheduled at 6 and 12 months of inclusion and yearly thereafter. If varices reappear, new band ligation will follow.

Other Name: Non-selective beta blocker + Endoscopic variceal ligation

Study Arm (s)

Experimental: TIPS treatment

TIPS will be performed as soon as possible once the patients are enrolled in the study, always within the first 72 hours after the diagnostic endoscopy (preferably in the first 24 hours).

Patients will be treated with non-selective beta-blockers (either propranolol or nadolol). In case of contraindications or intolerance to beta-blockers, patients will not receive pharmacological treatment (beta-blockers but also mononitrate) and the only treatment to prevent rebleeding will be endoscopic band ligation.